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AbbVie (ABBV) Adds FDA-Issued New Warnings to Rinvoq's Label

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AbbVie (ABBV - Free Report) announced that it is updating prescribing information and medication guide of its  JAK inhibitor, Rinvoq (upadacitinib) in the United States to include new warnings following a Drug Safety Communication (“DSC”) issued by the FDA in September.

The FDA issued the DSC following the final review of a post-marketing study that evaluated another JAK inhibitor, Pfizer’s (PFE - Free Report) Xeljanz in patients with rheumatoid arthritis (“RA”).

The updated Rinvoq label includes boxed warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death.

Per the new label update for Rinvoq, the FDA is limiting approved use of the drug to certain RA patients who have not responded or cannot tolerate one or more tumor necrosis factor (TNF) blockers, which include AbbVie’s Humira that is approved for multiple inflammatory indications.

AbbVie’s stock has risen 10.9% this year so far compared with an increase of 12.4% for the industry.

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Why New Warnings?

In September, the FDA issued a directive that the labels of three JAK inhibitor medicines — Pfizer’s Xeljanz, AbbVie’s Rinvoq, and Lilly (LLY - Free Report) and Incyte’s (INCY - Free Report) Olumiant (baricitinib) — approved to treat certain chronic inflammatory conditions should include warnings about an increased risk of serious heart-related events, cancer, blood clots, and even death. In addition, the FDA limited all approved uses of these three medicines to certain patients who have not responded or cannot tolerate one or more TNF blockers.

The FDA’s decision was based on data from the post-marketing study of Pfizer’s Xeljanz that compared it to another class of drugs — TNF inhibitors. Data from the study demonstrated that treatment with Pfizer’s Xeljanz may increase the risk of heart-related problems and cancer. The post-marketing safety study failed to show the non-inferiority of Pfizer’s Xeljanz to a TNF inhibitor with regard to major adverse cardiovascular events and malignancies.

The FDA’s review of the final data from the study showed that patients treated with both low as well as high doses of Pfizer’s Xeljanz experienced a higher rate of serious heart-related events such as heart attack and stroke, cancer, blood clots, and death compared to those treated with TNF inhibitors. Previously, the FDA thought that only a higher dose of PFE’s Xeljanz would increase such risks.

We note that Lilly and Incyte's Olumiant is approved for treating moderately to severely active RA.

Lilly and Incyte are seeking approval for the label expansion of Olumiant as a treatment for atopic dermatitis. However, the FDA has extended the review of the regulatory application for the same earlier this year, primarily due to the ongoing review of the post-marketing study data on PFE’s Xeljanz. Lilly and Incyte plan to file a label expansion application with the FDA for label expansion of Olumiant as a treatment for alopecia areata by the end of this year. The candidate is currently being evaluated in late-stage studies as a potential treatment for systemic lupus erythematosus by Lilly and Incyte.

We remind investors that supplemental new drug applications (sNDAs) for label expansions of Rinvoq to include treatment of atopic dermatitis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis are under review with the FDA.

Potential Impact of New Warnings

The FDA had stated in its DSC that the warnings and label update for JAK-inhibitors are not restricted to RA but also include other inflammatory diseases.

Rinvoq is a key new drug in AbbVie’s portfolio, which, along with another new drug, Skyrizi is gradually lowering AbbVie’s dependence on its main immunology medicine, Humira. Humira has been facing biosimilar competition in Europe since 2019 that has significantly hurt its sales in the international market. The drug is set to face biosimilar completion in the United States, its major revenue-generating territory, in 2023.

AbbVie was expecting that with many new indications expected to be approved in the next couple of years, sales of these drugs could be higher and have the potential to replace Humira when generics are launched in 2023. AbbVie expects the combined revenues of these two drugs to be more than $15 billion by 2025. However, with new warnings on Rinvoq’s labels, AbbVie might not be able to meet its sales target for the drug.

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AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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